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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021807
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLTAMOX TAMOXIFEN CITRATE EQ 20MG BASE/10ML SOLUTION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/29/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021807ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021807s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2019 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021807Orig1s006ltr.pdf
09/25/2018 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021807Orig1s005ltr.pdf
04/22/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/28/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2019 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf
04/08/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf
09/25/2018 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf
10/29/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf
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